bone metastasis in patients with breast cancer MedDRA version: 6.1 Level: PT Classification code 10027452
Conditions
Interventions
Product Name: ZOLEDRONIC ACID
Product Code: ZOL446
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients 18 years of age. Written informed consent given. Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed. Life expectancy 1 year. Treatment with Zometa every 3-4 weeks, for 9-12 infusions over no more than 15 months. ECOG performance status 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: More than 3 months since last infusion of Zometa. Treatments with other bisphosponates than Zometa at any time prior to study entry. Serum creatinine 3 mg/dL 265 mol/L or calculated Cockcroft-Gault formula creatinine clearance CLCr 30 mL/min CrCl 140-age years x weight kg x 0.85 72 x serum creatinine mg/dL Corrected adjusted for serum albumin serum calcium 8 mg/dl 2 mmol/L or 12 mg/dL 3.0 mmol/L . Current active dental problem including infection of the teeth or jawbone maxilla or mandibular ; dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw ONJ , of exposed bone in the mouth, or of slow healing after dental procedures. Recent within 6 weeks or planned dental or jaw surgery e.g. extraction, implants . Pregnant patients with a positive pregnancy test prior to study entry or lactating patients. Women of childbearing potential not using effective methods of birth control e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide . History of non-compliance to medical regimens or potential unreliable behavior. Known sensitivity to study drug s or class of study drug s . Patients with severe medical condition s that in the view of the investigator prohibits participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy skeletal morbidity rate of Zometa administered every three months versus Zometa given every 4 weeks in patients with bone metastasis from breast cancers who have been previously treated with Zometa for 9-12 infusions.;Secondary Objective: To compare the two arms in respect to the occurrence of other SREs time and frequency and in respect to bone pain, analgesic consumption and bone turnover and tumor markers. proportion of patients experiencing SREs overall and by event time to first SRE annual incidence of any SREs by event SMR composite bone pain score according to the Brief Pain inventory/BPI questionnaire Appendix 1 use of analgesic medications according to the analgesic score Appendix 2 markers of bone turnover NTX, PTH and VEGF the substuy on the markers will be carried out in a limited number of patients ;Primary end point(s): The primary efficacy endpoint of this study is the annual overall Skeletal Morbidity Rate SMR . | — |
Countries
Italy
Outcome results
None listed